Exelixis NASDAQ: EXEL remains focused on expanding its CABO franchise while preparing for potential launches and data readouts tied to zanzalintinib, Andrew Peters, the company’s senior vice president of strategy, said during a session hosted by RBC Capital Markets.
Peters said Exelixis’ guidance reflects continued growth for CABO, driven by the company’s existing business and the launch in neuroendocrine tumors, or NETs. He said the company is focused on gaining market share in renal cell carcinoma, or RCC, while also building momentum in NETs.
“It’s really kind of that singular focus on making sure that we’re going out every day and talking about CABO, talking about the data, and that again, driving market share,” Peters said.
CABO Growth Centers on RCC and NETs
In RCC, Peters acknowledged that oncology remains highly competitive, including emerging activity around HIF-2 targeting therapies. He said Exelixis is closely watching recent and ongoing data in the space, including LITESPARK studies and the company’s own clinical efforts.
Peters said CABO remains the “number one IO/TKI” and “number one IO” in its market, and the company wants to preserve that position. He also noted investor discussion around whether adoption of lenvatinib in second-line RCC could support greater CABO use in the first-line setting, saying that would be an outcome Exelixis would be “okay with,” given duration dynamics.
On NETs, Peters said Exelixis has seen enthusiasm for CABO, particularly following the CABINET data. He said adoption began in the academic setting, but the company is also emphasizing community physicians, where many patients are treated. A recent sales force expansion is intended to support both the NET launch and lay groundwork for a potential zanzalintinib launch.
Peters said NETs are a relatively indolent disease, making refill dynamics important as patients remain on therapy. He said Exelixis’ guidance incorporates growth in both RCC and NETs.
Zanzalintinib Development Includes NET and Colorectal Cancer
Discussing zanzalintinib in NETs, Peters said the company sees differences between CABO and zanzalintinib, including what he described as a potentially more user-friendly profile, shorter half-life and potentially better tolerability based on earlier observations.
He contrasted CABINET, which evaluated a later-line population and was placebo-controlled, with the 3-11 study, which is intended to answer what should be the first oral option for certain NET patients. Peters said the study is in an earlier population and compares zanzalintinib head-to-head against everolimus, the current standard of care.
In colorectal cancer, Peters said the nearest-term zanzalintinib opportunity is tied to STELLAR-303. He said the study’s intent-to-treat population, which read out last year, includes patients with and without liver metastases and has a PDUFA date in December. Exelixis is also awaiting a data update in the non-liver metastasis population.
Peters said the ideal outcome would be a data set that allows the company’s commercial organization to communicate why zanzalintinib plus atezolizumab should become a standard of care for later-line colorectal cancer patients. He highlighted the potential importance of an immunotherapy-containing, chemotherapy-free regimen in a population that may have already received chemotherapy throughout much of its treatment journey.
Exelixis Preparing for Potential CRC Launch
Peters said Exelixis’ regulatory interactions have gone well so far, describing the process with the FDA as collegial and collaborative. He said the company has experience working with the agency and that the filing and review have proceeded as well as Exelixis could hope.
If approved, Peters said Exelixis intends to compete broadly across colorectal cancer treatment settings, targeting both academic and community prescribers. He said the company’s sales force expansion completed last quarter was designed not only to accelerate the NET launch but also to prepare for a potential zanzalintinib approval later this year.
Peters reiterated that Exelixis views the colorectal cancer opportunity as a potential $1.5 billion market when applying contemporary pricing and duration assumptions. He described the current later-line market as fragmented, with roughly one-third of patients treated with the SUNLIGHT regimen, one-third with TKIs and one-third with various chemotherapy-type options.
“Our goal, our mission, our singular focus, again, is to make sure that we’re taking as much share from each of those three buckets as we can,” Peters said.
RCC Strategy Looks Toward the 2030s
Exelixis is also awaiting data this year from STELLAR-304 in non-clear cell RCC. Peters said the area has limited data and no formally approved treatment options specific to the setting. He said current treatment decisions are often driven by inference from clear cell RCC and guideline recommendations based on sparse data sets.
Peters said Exelixis believes STELLAR-304 can provide robust evidence to help define treatment for non-clear cell RCC patients. He described non-clear cell RCC as a meaningful opportunity because it represents about 20% of a large market.
More broadly, Peters said Exelixis sees zanzalintinib as central to its next phase in RCC. He said CABO has been the TKI in RCC for the 2020s, while Exelixis wants zanzalintinib to be the TKI in RCC for the 2030s. The company is studying zanzalintinib across non-clear cell, post-adjuvant, frontline and later-line RCC settings.
Peters also discussed collaborations involving HIF inhibitors, including work with Merck. He said Exelixis believes combinations such as zanzalintinib with belzutifan could help answer important treatment questions, including what patients should receive if cancer returns after adjuvant pembrolizumab.
MRD-Positive Colorectal Cancer Study Adds New Approach
Peters also highlighted the 316 study, an adjuvant trial in minimal residual disease-positive colorectal cancer patients. The study involves Natera’s Signatera test and evaluates zanzalintinib alone or in combination with Merck’s Keytruda.
He said ctDNA testing can identify patients at high risk of relapse, but the current standard is largely to watch and wait. Peters said Exelixis hopes the study can determine whether zanzalintinib, with or without Keytruda, can extend disease-free survival for these patients.
He said Exelixis is working with Natera to operationalize the study and believes the ability to identify eligible patients could support clinical trial execution.
About Exelixis NASDAQ: EXEL
Exelixis, Inc is a biotechnology company specializing in the discovery, development and commercialization of small molecule therapies primarily for the treatment of cancer. Building on a platform that leverages model organism genetics and high-throughput screening, the company focuses its research on kinase inhibitors that modulate critical signaling pathways involved in tumor growth and metastasis. Exelixis's translational research approach aims to advance novel compounds from early-stage discovery through clinical development and regulatory approval.
The company's most recognized products include CABOMETYX® (cabozantinib), approved for the treatment of advanced renal cell carcinoma and hepatocellular carcinoma, and COMETRIQ® (cabozantinib) for metastatic medullary thyroid cancer.
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